510(k) K234008
- Device
- CERAMENT G
- Applicant
- Bonesupport AB
- 510(k) number
- K234008
- Product code
- QRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-13
- Date received
- 2023-12-19
- Regulation
- 888.3046
- Classification name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Blerta Shuka
- Address
- Scheelevagen 19 Ideon Science Park Se-223 70 Lund SE
FDA Registration Numbers#
- 3004681519
- 3010413864
- 3005304945
Source Documents#
Other 510(k) Records For Product Code QRR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN210044 | CERAMENT G | Bonesupport AB | 2022-05-17 |